Injectafer® (ferric carboxymaltose injection) Receives FDA Approval for Single Dose Option for the Treatment of Adult Patients with Iron Deficiency Anemia
For patients weighing 50 kg (110 lb) or more, Injectafer may now be administered as a 1000 mg single dose for IDA treatment¹
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BASKING RIDGE, N.J. and SHIRLEY, N.Y., May 6, 2021 /PRNewswire/ Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, today announced that the U.S. Food and Drug Administration (FDA) has approved a single 1000 mg dose option of Injectafer
® (ferric carboxymaltose injection), an iron replacement product, for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron, have had unsatisfactory response to oral iron, or have non-dialysis dependent chronic kidney disease (CKD).
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MDR”), which will govern medical devices software (“
MDSW”) in the EU, we turn to the transition periods certain MDSW can benefit from before being required to fully comply with the MDR.
Transitional periods are provided in Article 120 MDR. In part due to the COVID-19 pandemic, the original text of Article 120 MDR has been corrected by two corrigenda (I, II) and another Regulation to avoid additional burdens to stakeholders and impasses in the supply of medical devices. The changes introduced by these amendments are twofold: On the one hand, the scope of the existing transitional periods was substantially changed and now includes more devices. On the other hand, the MDR now reflects the pushed-back applicability dates of the MDR and their influence on the transitional periods.
How To Navigate Clinical Data Per EU MDR
By Matthias Fink, MD, TÜV SÜD America
In May 2017, the European Medical Devices Regulation (MDR) 2017/745 was published to replace the current Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD). In April 2020, the European Parliament adopted the European Commission’s proposal to postpone the Date of Application (DoA) of the MDR by one year, and as such, the new DoA is May 26, 2021. It is worth noting that the end of the transition period for MDD and AIMDD certificates remains May 26, 2024, thus reducing the timeline for manufacturers to get their MDR certificates from four to three years.
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After having dealt with the issue when software may be considered a medical device according to its
intended purpose (in part 2) and the implications of the new
risk classification regime (in part 3), in this part 4 of our series on Software as a Medical Device in Europe, we will now explore key changes to the quality assurance and documentation requirements for stand-alone medical device software (“
MDR”).
INTRODUCTION: A NEW LIFE CYCLE-FOCUSED APPROACH
MDD”) primarily focusses on the pre-approval stage of a medical device and how the manufacturer can obtain the CE marking, the MDR deploys a product life cycle-focused approach, aiming to establish responsibilities of medical device companies throughout the life cycle of the product. While not all requirements are new, to ensure conformity of the MDSW with the MDR, detailed and partly enhanced requirements concerning quality management, risk management, clini